Teva Pharmaceutical Industries has obtained approval from the European Commission for an indication extension of Trisenox (arsenic trioxide).
The extension is for newly diagnosed, low-to-intermediate-risk, acute promyelocytic leukaemia (APL) in combination with retinoic acid.
APL is a rare and aggressive type of acute leukaemia that can kill within hours or days if left untreated.
In combination with retinoic acid, Trisenox has shown a 99% overall survival rate with almost no relapses after more than four years of median follow-up.
Teva global specialty medicines president and CEO Rob Koremans said: “Teva is committed to providing wider access to high-quality medicines to ensure more people can benefit from the treatments they need.
“We’re very pleased by this decision of the European Commission, and we look forward to offering a chemotherapy-free treatment option for all newly diagnosed APL patients.”
The approval grants marketing authorisation for first-line use of Trisenox in the 28 countries of the European Union.
Treating low-to-intermediate-risk APL with a chemo-free regimen of Trisenox plus retinoic acid is expected to increase survival rates and reduce the risk of relapse.
University of Rome Tor Vergata, Italy Laboratory of Integrated Diagnosis of Oncohematologic Diseases, Department of Biomedicine and Prevention head Francesco Lo-Coco said: “This approval by the European Commission is good news for APL patients as we now have access to a cure for an acute leukaemia without using chemotherapy.
“From now on, APL patients with non-high-risk disease will have access to this chemotherapy-free regimen of Trisenox plus retinoic acid at diagnosis, which has the potential to increase survival rates while minimising side effects associated with chemotherapy.”
APL is a form of acute myeloid leukaemia (AML), a cancer of the blood-forming tissue.